Marinus Pharmaceuticals has offered up the European rights for antiseizure medicine ganaxolone to Orion in exchange for a $30 million upfront fee and milestones.
Radnor, Pennsylvania-based Marinus could receive up to $115 million later on in reimbursement, development and commercialization milestone payments as well as royalties on sales. The upfront payment is subject to certain provisions related to some additional preclinical testing that Marinus will need to complete. This work is expected to wrap up in the first quarter of 2022.
The commercialization deal grants Orion rights to ganaxolone in the European economic area, the U.K. and Switzerland for the oral and IV formulations of the therapy to treat CDKL5 deficiency disorder (CDD), tuberous sclerosis complex and refractory status epilepticus.
The deal will tap into Orion’s “extensive commercial infrastructure” across Europe and expertise in rare neurological disorders, Marinus said in a statement.
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Marinus will continue clinical development of the therapy and move it through the regulatory process in Europe. A filing in the region is expected by the end of the third quarter.
Orion, meanwhile, will be responsible for pricing and reimbursement approvals and commercialization in the specified regions.
Ganaxolone is set to launch in mid-2022 so long as it gains approval to treat patients with CDD. The childhood seizure disorder impairs development of motor skills and causes other complications.
Marinus has had a tough go with ganaxolone, which previously failed to beat placebo in a phase 3 test in adult focal onset seizures. That program was ultimately abandoned, but the company has seen greater success in CDD.